Integrated sensor for medical applications

ABSTRACT

A sensing assemblage for capturing a transit time, phase, or frequency of energy waves propagating through a medium is disclosed to measure a parameter of the muscular-skeletal system. The sensing assemblage comprises a transducer and a waveguide. The transducer is coupled to the waveguide at a first location. A reflective surface can be coupled to the waveguide at a second location. The reflective surface is configured to reflect energy waves away from the reflective surface. An interface material that is transmissive to acoustic energy waves can be placed between the transducer and a waveguide to improve transfer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of application Ser. No. 12/825,770filed on 29 Jun. 2010. This application further claims the prioritybenefit of U.S. provisional patent applications No. 61/221,761,61/221,767, 61/221,779, 61/221,788, 61/221,793, 61/221,801, 61/221,808,61/221,817, 61/221,867, 61/221,874, 61/221,879, 61/221,881, 61/221,886,61/221,889, 61/221,894, 61/221,901, 61/221,909, 61/221,916, 61/221,923,and 61/221,929 all filed 30 Jun. 2009; the disclosures of which arehereby incorporated herein by reference in their entirety.

FIELD

The present invention relates generally to measurement of physicalparameters, and more particularly, real-time measurement of load, force,pressure, displacement, density, viscosity, or localized temperature bychanges in the transit time of waves propagating within waveguidesintegrated within sensing modules or devices placed on or within a body,instrument, appliance, vehicle, equipment, or other physical system.

BACKGROUND

The skeletal system of a mammal is subject to variations among species.Further changes can occur due to environmental factors, degradationthrough use, and aging. An orthopedic joint of the skeletal systemtypically comprises two or more bones that move in relation to oneanother. Movement is enabled by muscle tissue and tendons attached tothe skeletal system of the joint. Ligaments hold and stabilize the oneor more joint bones positionally. Cartilage is a wear surface thatprevents bone-to-bone contact, distributes load, and lowers friction.

There has been substantial growth in the repair of the human skeletalsystem. In general, orthopedic joints have evolved using informationfrom simulations, mechanical prototypes, and patient data that iscollected and used to initiate improved designs. Similarly, the toolsbeing used for orthopedic surgery have been refined over the years buthave not changed substantially. Thus, the basic procedure forreplacement of an orthopedic joint has been standardized to meet thegeneral needs of a wide distribution of the population. Although thetools, procedure, and artificial joint meet a general need, eachreplacement procedure is subject to significant variation from patientto patient. The correction of these individual variations relies on theskill of the surgeon to adapt and fit the replacement joint using theavailable tools to the specific circumstance.

BRIEF DESCRIPTIONS OF DRAWINGS

Various features of the system are set forth with particularity in theappended claims. The embodiments herein, can be understood by referenceto the following description, taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 is a cross-sectional view of an example sensing assemblage inaccordance with one embodiment;

FIG. 2 is a side view of an alternate embodiment of the sensingassemblage having two transducers;

FIG. 3 is an exemplary assemblage for illustrating reflectance andunidirectional modes of operation in accordance with an exemplaryembodiment;

FIG. 4 is an exemplary assemblage that illustrates propagation ofultrasound waves within the waveguide in the bi-directional mode ofoperation of this assemblage;

FIG. 5 illustrates in one embodiment the components of the integratedsensing assemblage;

FIG. 6 illustrates the components of integrated sensing assemblage inaccordance with one embodiment;

FIG. 7 is a flow chart of an exemplary method of assembling theintegrated sensing assemblage;

FIG. 8 is an illustration of a load sensing insert device placed incontact between a femur and a tibia for measuring a parameter inaccordance with an exemplary embodiment;

FIG. 9 is a perspective view of the medical device in accordance withone embodiment;

FIG. 10 is an exemplary block diagram of the components of a sensingmodule; and

FIG. 11 is an illustration of a plot of non-overlapping resonantfrequencies of paired transducers in accordance with an exemplaryembodiment.

DETAILED DESCRIPTION

Embodiments of the invention are broadly directed to an integratedsensing device that measures applied forces, and more particularly, tosensing assemblies used therein for evaluating characteristics of energywaves propagating within waveguides. The waveguides are a conduit forguiding various kinds of waves. Changes in the compression of thewaveguide are measured to evaluate changes in the applied forces. As anexample, a transit time or shape of the energy wave or pulse propagatingthrough the waveguide can be measured to determine the forces acting onthe waveguide.

In all of the examples illustrated and discussed herein, any specificmaterials, temperatures, times, energies, etc. for process steps orspecific structure implementations should be interpreted to illustrativeonly and non-limiting. Processes, techniques, apparatus, and materialsas known by one of ordinary skill in the art may not be discussed indetail but are intended to be part of an enabling description whereappropriate.

Note that similar reference numerals and letters refer to similar itemsin the following figures. In some cases, numbers from priorillustrations will not be placed on subsequent figures for purposes ofclarity. In general, it should be assumed that structures not identifiedin a figure are the same as previous prior figures.

The propagation velocity of the energy waves or pulses in the waveguideis affected by physical changes of the waveguide. The physical parameteror parameters of interest can include, but are not limited to,measurement of load, force, pressure, displacement, density, viscosity,localized temperature. These parameters can be evaluated by measuringchanges in the propagation time of energy pulses or waves in a waveguiderelative to orientation, alignment, direction, or position as well asmovement, rotation, or acceleration along an axis or combination of axesby wireless sensing modules or devices positioned on or within a body,instrument, appliance, vehicle, equipment, or other physical system.

FIG. 1 is a side view of an example sensing assemblage 1 in accordancewith one embodiment. Sensing assemblage 1 comprises an ultrasoundwaveguide 3 and ultrasound resonator or transducer 2, and a reflectingfeature 5. The transducer 2 is coupled to waveguide 3 and can includeinterfacing material or materials therebetween. The interfacing materialor materials promote the transfer of an acoustic signal betweentransducer 2 and waveguide 3. The sensing assemblage 1 enables thegeneration, propagation, and detection of ultrasound waves 4 withinwaveguide 1. In the example, the ultrasound resonator or transducer 2and interfacing material or materials, if required, are placed incontact with, attached, or affixed to an end of waveguide 1 andultrasound wave 4 is reflected from the opposite end of waveguide 3 orother feature or features 5 within waveguide 3. This sensing assemblageis operated in a reflectance mode. The ultrasound resonator ortransducer 2 is controlled by way of controller 9 to both emitultrasound waves 4 into waveguide 3 and detect the echo of reflectedwaves 6 propagating from a reflective surface 10 on one end of waveguide3 or from reflecting feature 5. This arrangement facilitates translatingchanges in the length or compression of waveguide 3 due to a force 8applied to contact surfaces into a change in the transit time 7 ofultrasound waves 4. Sensing assemblage 1 allows the translation ofchanges in an external parameter or parameters of interest applied towaveguide 3 into electrical signals.

The sensing assemblage 1 by way of controller 9 can measure appliedforces 8. For example, briefly referring ahead, FIG. 8 shows oneembodiment of a wireless sensing device 100 comprising one or moresensing assemblages. In this embodiment, the wireless sensing device byway of the sensing assemblages can assess load forces, measure amagnitude and distribution of load at various points and transmit themeasured load data by way of data communication to a receiving station.

As will be explained ahead in FIG. 10, electronic assemblage within thewireless sensing device 100 integrates a power supply, sensing elements,ultrasound resonator or resonators or transducer or transducers andultrasound waveguide waveguides, biasing spring or springs or other formof elastic members, an accelerometer, antennas and electronic circuitrythat processes measurement data as well as controls all operations ofultrasound generation, propagation, and detection and wirelesscommunications. The electronics assemblage also supports testability andcalibration features that assure the quality, accuracy, and reliabilityof the completed wireless sensing module.

Referring back to FIG. 1, integration of components for accuratelymeasuring the length of ultrasound waveguides includes integratingultrasound resonators or transducers at one or both ends of anultrasound waveguide consisting of ultrasound media. Appropriateintegration of this sensing assemblage enables the flexibility to sizethe completed sensing assemblage from highly compact to as large asrequired to fit the application. The sensing assemblage may bepositioned or attached or affixed, in coordination with calibratedsprings or other means of elastic support, between the load bearing orcontacting surfaces of a sensing module or device. In other embodiments,the ultrasound waveguide may be constructed of ultrasound media withelastic properties that eliminate the requirement for separate springsor other means of elastic structures to support the load bearing orcontacting surfaces. For these embodiments of the integrated sensingassemblage, ultrasound waveguide material having the properties ofdeforming monotonically and linearly when compressed or stretched, andrelaxing quickly without hysteresis or developing a compression orextension set are selected. In all embodiments the integrated sensingassemblage either alone, or in conjunction with springs or other meansof elastic support, attached to, or positioned or affixed between, theload bearing or contact surfaces of a sensing module or device,translates load, force, pressure, density, viscosity, localizedtemperature, or displacement applied to the load bearing or contactingsurfaces into an accurately controlled changes in the length of theultrasound waveguide.

For applications requiring a highly compact sensing module or device,the ultrasound waveguides may be as miniaturized, but are not limitedto, as lengths on the order of a millimeter. The sensing assemblage alsosupports submicron resolution of changes in the compression or extensionof the ultrasound waveguide or waveguides over a wide range of lengths.The capability to construct highly compact sensing assemblages enablesconstruction and operation of highly miniaturized sensing modules ordevices constructed using standard components and manufacturingprocesses. Larger scale sensing assemblages are readily constructedusing standard components and manufacturing processes.

The relationship of the propagation of ultrasound in a medium withrespect to the aspect ratio of the piezoelectric element is well known.Ultrasound waves propagate linearly through the waveguide thusmaintaining an accurate relationship between compression or extensionand transit time of ultrasound waves. This enables accurate conversionof mechanical changes in the length or compression or extension of thewaveguide into changes in the transit time of ultrasound waves or pulseswithin the waveguide.

FIG. 2 is a side view of an alternate embodiment of the sensingassemblage 1 having two transducers. The illustration provides anotherembodiment of sensing assemblage 1 comprising ultrasound waveguide 3,ultrasound transducer 2, and an ultrasound transducer 3. Ultrasoundtransducers 2 and 11 are respectively coupled to a first location andsecond location of waveguide 3. In one embodiment, waveguide 3 iscylindrically in shape having a first and second end to whichtransducers are coupled. Sensing assemblage 1 supports the generation,propagation, and detection of ultrasound waves 4 within the waveguide 3.The ultrasound resonators or transducers 2 and 11 in combination withinterfacing material or materials, if required, are placed in contactwith, or attached or affixed to, both ends of the waveguide 3. Thissensing assemblage can be operated in reflectance, unidirectional, orbi-directional modes. The arrangement facilitates translating changes inthe length or compression of waveguide 3 by changes in external forcesor conditions 8 into changes in the transit time 7 of ultrasound waves 4and enabling the translation of changes in an external parameter orparameters of interest into electrical signals. The sensing assemblageby way of controller 9 can measure applied forces 8.

In general, an energy wave is directed within one or more waveguides ina device by way of continuous wave mode, pulse mode, pulse-echo mode,and pulse shaping. The waveguide 3 is a conduit that directs the energypulse in a predetermined direction. The energy pulse is typicallyconfined within the waveguide. In one embodiment, the waveguidecomprises a polymer material. For example, urethane or polyethylene arepolymers suitable for forming a waveguide. In one embodiment, thewaveguide can be compressed and has little or no hysteresis in thesystem. The waveguide can be cylindrical in shape. A parameter appliedto waveguide 3 affects a length of the waveguide 3. A relationshipbetween the length of the waveguide 3 and the parameter is known. In anon-limiting example, the propagation time of an energy wave inwaveguide 3 is measured. The length of waveguide 3 corresponds totransit time 7 and is calculated from the measurement of transit time 7.The known relationship between the length and the parameter beingmeasured is then used to calculate the parameter value.

FIG. 3 is an exemplary assemblage 400 for illustrating reflectance andunidirectional modes of operation in accordance with an exemplaryembodiment. In one embodiment, assemblage 400 shows the propagation ofultrasound waves 418 within waveguide 414 in the reflectance andunidirectional modes of operation. A parameter to be measured is appliedto waveguide 414. In a non-limiting example, a change in the parameterchanges a dimension of the waveguide 414. A sensor system translateschanges in the length or compression of waveguide 414 into changes inthe transit time of ultrasound waves 418. Thus, assemblage 400 changesan external parameter or parameters of interest into electrical signalsthat can be further processed. Each ultrasound resonator or transducer(402, 404) in combination with interfacing material or materials (408,410), if required, are placed in contact with, or attached or affixedto, both ends of the waveguide (420, 422). Either ultrasound resonatoror transducer 402 or 404 may be selected to emit ultrasound waves, forexample ultrasound resonator or transducer 402 in contact with, orattached or affixed to, one end (420) of waveguide 414, may be selectedto emit ultrasound wave 418 into waveguide 414. The sensing assemblagecan be operated in reflectance mode and ultrasound waves 418 may bedetected by the emitting ultrasound resonator or transducer, in thisexample ultrasound resonator or transducer 402, after reflection fromthe opposite end 422 of waveguide 414 by reflecting feature, surface,interface, or body positioned at the opposite end 422 of the waveguide.In this mode, either of the ultrasound resonators or transducers 402 or404 may be selected to emit and detect ultrasound waves.

The design of waveguide 414 supports sensing across multiple dimensionsthereby permitting sensing of load forces in three-dimensions (e.g., x,y and z). By way of controller 9 (see FIG. 1) changes in length Δx canbe sensed along the waveguide propagating path formed by transducers 402and 404 because of compression forces acting along the x-dimension. Thecontroller 9 in view of Δx can further sense changes in length Δy alongthe waveguide propagating path formed by transducers 402 and 406 becauseof compression forces acting along the y-dimension. A waveguidepropagating path can also be present in the z-dimension (e.g., into orout of the page) for providing sensing along the z-dimension in view ofΔx and Δy. Although the physical orientation of the propagating channelsare shown at right angles (90 degrees), other embodiments can includepropagating channels at different angles, for example, to measurerotation or torque.

The physical structure and orientation of the waveguide 414 in such anarrangement supports two modes of operation; reflectance mode andunidirectional mode. Unidirectional mode occurs along a direct pathbetween a transmitter and a receiver. For instance, this occurs whentransducer 402 transmits ultrasonic waves 418 along the waveguidepropagating path to receiving transducer 404. In contrast, reflectancemode can occur as a result of the reflector 416 being positioned alongthe waveguide propagating path as shown to deflect sound waves totransducer 406 in the y-direction. The constructive design of thepropagating channels in the waveguide 414 allows compression alongmultiple dimensions of the waveguide to permit measurements of thechanges in length of the waveguide in three-dimensions. The compressionoccurs responsive to external load forces acting on the sensingassemblies that generates measurable compression characteristics.

In either mode, ultrasound waves 418 are generated by ultrasoundresonator or transducer 402, 404, or 406 in combination with interfacingmaterial or materials 408, 410, or 412. The ultrasound waves 418propagate within the waveguide 414 in either reflectance mode or inunidirectional mode of operation. When operated in reflectance mode, theultrasound waves 418 can be detected by the emitting ultrasoundresonator or transducer after reflection—from the opposite end of thewaveguide—by reflecting feature, surface, interface, or body at theopposite end of the waveguide thus enabling the conversion of changes inthe length of compression of the waveguide 414 into electrical signals.In this mode, either of the ultrasound resonators or transducers 402,404, or 406 may be selected to emit and detect ultrasound waves.

In unidirectional mode example, the ultrasound resonators or transducers402 is controlled to emit ultrasound waves 418 into the waveguide 414.The other ultrasound resonator or transducer 404 is controlled to detectthe ultrasound waves 418 emitted by the emitting ultrasound resonator ortransducer 402. Additional reflectors 416 can be added within thewaveguide 414 to reflect ultrasound waves. This can support operation ina combination of unidirectional and reflectance modes. In this mode ofoperation, one of the ultrasound resonators or transducers 402 iscontrolled to emit ultrasound waves 418 into the waveguide 414. Anotherultrasound resonator or transducer 406 is controlled to detect theultrasound waves 418 emitted by the emitting ultrasound resonator ortransducer 402 subsequent to their reflection by reflector 416 thusenabling the conversion of changes in the length of compression of thewaveguide 414 into electrical signals.

FIG. 4 is an exemplary assemblage 500 that illustrates propagation ofultrasound waves 510 within the waveguide 506 in the bi-directional modeof operation of this assemblage. In this mode, the selection of theroles of the two individual ultrasound resonators or transducers (502,504) affixed to interfacing material 520 and 522, if required, areperiodically reversed. In the bi-directional mode the transit time ofultrasound waves propagating in either direction within the waveguide506 can be measured. This can enable adjustment for Doppler effects inapplications where the sensing module 508 is operating while in motion516. Furthermore, this mode of operation helps assure accuratemeasurement of the applied load, force, pressure, or displacement bycapturing data for computing adjustments to offset this external motion516. An advantage is provided in situations wherein the body,instrument, appliance, vehicle, equipment, or other physical system 514,is itself operating or moving during sensing of load, pressure, ordisplacement. Similarly, the capability can also correct in situationwhere the body, instrument, appliance, vehicle, equipment, or otherphysical system, is causing the portion 512 of the body, instrument,appliance, vehicle, equipment, or other physical system being measuredto be in motion 516 during sensing of load, force, pressure, ordisplacement. Other adjustments to the measurement for physical changesto system 514 are contemplated and can be compensated for in a similarfashion. For example, temperature of system 514 can be measured and alookup table or equation having a relationship of temperature versustransit time can be used to normalize measurements. Differentialmeasurement techniques can also be used to cancel many types of commonfactors as is known in the art.

In bi-directional mode ultrasonic waves 510 propagate between resonatorsor transducers 502 and 504 positioned at opposing ends of the ultrasoundwaveguide 506. This mode of operation helps assure accurate measurementof the applied load, force, pressure, displacement, density, localizedtemperature, or viscosity by capturing data for computing adjustments tooffset this external motion. In bi-directional mode the selection of theroles of the two individual ultrasound resonators or transducers 502 and504 with interfacing material or materials 520 and 522, if required, areperiodically reversed, or intermittently scheduled, for example, undercontrol of a processor. In this mode the transit time of ultrasoundwaves 510 propagating in either direction within the waveguide 506 canbe measured.

The use of waveguide 506 enables the construction of low cost sensingmodules and devices over a wide range of sizes, including highly compactsensing modules, disposable modules for bio-medical applications, anddevices, using standard components and manufacturing processes. Theflexibility to construct sensing modules and devices with very highlevels of measurement accuracy, repeatability, and resolution that canscale over a wide range of sizes enables sensing modules and devices tothe tailored to fit and collect data on the physical parameter orparameters of interest for a wide range of medical and non-medicalapplications.

Appropriate integration of this sensing assemblage enables theflexibility to size the completed sensing assemblage from highly compactto as large as required to fit the application. The sensing assemblagemay be positioned or attached or affixed, in coordination withcalibrated springs or other means of elastic support, between the loadbearing or contacting surfaces of a sensing module or device. In otherembodiments the ultrasound waveguide may be constructed of ultrasoundmedia with elastic properties that eliminate the requirement forseparate springs or other elastic structures to support the load bearingor contact surfaces of a sensing module or device. In all embodimentsthe integrated sensing assemblage either alone, or in conjunction withsprings or other means of elastic support, attached to, or positioned oraffixed between, the load bearing or contact surfaces of a sensingmodule or device, translates load, force, pressure, displacement,density, viscosity, or localized temperature applied to those loadbearing or contacting surfaces into an accurately controlledcompression, extension, or displacement of the length of the ultrasoundwaveguide.

For example, sensing modules or devices may be placed on or within, orattached or affixed to or within, a wide range of physical systemsincluding, but not limited to instruments, appliances, vehicles,equipments, or other physical systems as well as animal and humanbodies, for sensing the parameter or parameters of interest in real timewithout disturbing the operation of the body, instrument, appliance,vehicle, equipment, or physical system.

In addition to non-medical applications, examples of a wide range ofpotential medical applications may include, but are not limited to,implantable devices, modules within implantable devices, modules ordevices within intra-operative implants or trial inserts, modules withininserted or ingested devices, modules within wearable devices, moduleswithin handheld devices, modules within instruments, appliances,equipment, or accessories of all of these, or disposables withinimplants, trial inserts, inserted or ingested devices, wearable devices,handheld devices, instruments, appliances, equipment, or accessories tothese devices, instruments, appliances, or equipment. Many physiologicalparameters within animal or human bodies may be measured including, butnot limited to, loading within individual joints, bone density,movement, various parameters of interstitial fluids including, but notlimited to, viscosity, pressure, and localized temperature withapplications throughout the vascular, lymph, respiratory, and digestivesystems, as well as within or affecting muscles, bones, joints, and softtissue areas. For example, orthopedic applications may include, but arenot limited to, load bearing prosthetic components, or provisional ortrial prosthetic components for, but not limited to, surgical proceduresfor knees, hips, shoulders, elbows, wrists, ankles, and spines; anyother orthopedic or musculoskeletal implant, or any combination ofthese.

FIG. 5 illustrates in one embodiment the components of integratedsensing assemblage 1. In one embodiment, sensing assemblage 1 includesinterface material or materials 3 between ultrasound waveguide 3 andtransducer 2. The interface materials 3 can aid in the transfer ofacoustic energy. The ultrasound resonator or transducer 2 includesintegrated electrical contacts 520 and 522 for connection withelectronic driving and data capture circuitry (see FIG. 10). Theultrasound resonator or transducer 2 with interface material ormaterials 524, if required, is positioned in contact with, or attachedor affixed to an end of ultrasound waveguide 3. In one example,interface material 3 is an adhesive that attaches transducer 2 to asurface of waveguide 3. The adhesive is a conductor of ultrasonicsignals and maximizes surface area contact. Alternatively, the sensingassemblage 1 can be held under pressure such that the interfaces ofwaveguide 3 and transducer 2 are held under a predetermined force incontact with one another. The slight pressure maintains contact thatpromotes the transfer of acoustic signals at the interface but does notaffect the measurement range of the sensing assemblage 1.

FIG. 6 illustrates the components of integrated sensing assemblage 1 inaccordance with one embodiment. In one embodiment, sensing assemblage 1comprises transducer 2, transducer 11, interfacing material 524,interfacing material 532, and waveguide 3. Transducer 2 includescontacts 520 and 522 for connection with electronic driving and datacapture circuitry. Similarly, transducer 11 includes contacts 550 and552 for connection with electronic driving and data capture circuitry.Transducer 2 is coupled to waveguide 3 at a first location. As shown, aninterfacing material 524 or media is placed between transducer 2 andwaveguide 3. Transducer 11 is coupled to waveguide 3 at a secondlocation. An interfacing material 532 is placed between transducer 11and waveguide 3. The interfacing material physically attaches to thewaveguide and a corresponding transducer. The interfacing material 524and 532 is transmissive to energy waves. In an alternate embodiment, areflecting feature or may be added to the waveguide for more complexmeasurement tasks.

FIG. 7 is a flow chart of an exemplary method of assembling theintegrated sensing assemblage. The method 700 can include more or lessthan the number of steps shown, and is not limited to the order of thesteps shown. For illustration purposes, with reference to FIG. 5, asingle ultrasound resonator or transducer 2 with an interfacing materialor materials 524 is shown. The embodiment of the integrated sensingassemblage 1 is in contact with ultrasound waveguide 3. Embodiments ofthe integrated sensing assemblage 1 with two ultrasound resonators ortransducers as shown in FIG. 6 are assembled in the same manner.

Referring back to FIG. 7, in a step 701 transducers or interfacingmaterials are assembled together to produce the sensing assembly. As anexample, the transducers can be affixed or connected to ends of thewaveguide. An optional test as part of the method steps can then beperformed on the sensing assembly to evaluate assembly integrity. In astep 702, the sensor assembly is coupled with the load sensing platform(e.g., springs, discs, posts, etc.). An optional test as part of themethod steps can then be performed to evaluate coupling integrity. In astep 703, the load sensing platform can be integrated with the sensingelectronics to produce an integrated force sensor. An optional test aspart of the method steps can then be performed to evaluate integration.In step 704, the integrated force sensor can be hermetically sealed toproduce an encapsulated enclosure. An optional test as part of themethod steps can then be performed to evaluate the sealing. In a step705, a detachable interface tag can be included to indicate completion.The tag can thereafter be removed during an insert procedure.

FIG. 8 is an illustration of a load sensing insert device 100 placed incontact between a femur 102 and a tibia 108 for measuring a parameter inaccordance with an exemplary embodiment. In general, load sensing insertdevice 100 is placed in contact with or in proximity to themuscular-skeletal system to measure a parameter. In a non-limitingexample, device 100 is used to measure a parameter of amuscular-skeletal system during a procedure such as an installation ofan artificial joint. As illustrated, the device 100 in this example canintra-operatively assess a load on prosthetic components during thesurgical procedure. It can collect load data for real-time viewing ofthe load forces over various applied loads and angles of flexion. It canmeasure the level and distribution of load at various points on theprosthetic component and transmit the measured load data by way datacommunication to a receiver station 110 for permitting visualization.This can aid the surgeon in making any adjustments needed to achieveoptimal joint balancing.

The load sensing insert device 100, in one embodiment, comprises a loadsensing platform 121, an accelerometer 122, and sensing assemblies 123.This permits the sensing device 100 to assess a total load on theprosthetic components when it is moving; it accounts for forces due togravity and motion. In one embodiment, load sensing platform 121includes two or more load bearing surfaces, at least one energytransducer, at least one compressible energy propagating structure, andat least one member for elastic support. The accelerometer 122 canmeasure acceleration. Acceleration can occur when the load sensingdevice 100 is moved or put in motion. Accelerometer 122 can senseorientation, vibration, and impact. In another embodiment, the femoralcomponent 104 can similarly include an accelerometer 127, which by wayof a communication interface to the load sensing insert device 100, canprovide reference position and acceleration data to determine an exactangular relationship between the femur and tibia. The sensing assemblies123 can reveal changes in length or compression of the energypropagating structure or structures by way of the energy transducer ortransducers. Together the load sensing platform 121, accelerometer 122(and in certain cases accelerometer 127), and sensing assemblies 123measure force or pressure external to the load sensing platform ordisplacement produced by contact with the prosthetic components.

Incorporating data from the accelerometer 122 with data from the othersensing components 121 and 123 assures accurate measurement of theapplied load, force, pressure, or displacement by enabling computationof adjustments to offset this external motion. This capability can berequired in situations wherein the body, instrument, appliance, vehicle,equipment, or other physical system, is itself operating or movingduring sensing of load, pressure, or displacement. This capability canalso be required in situations wherein the body, instrument, appliance,vehicle, equipment, or other physical system, is causing the portion ofthe body, instrument, appliance, vehicle, equipment, or other physicalsystem being measured to be in motion during sensing of load, pressure,or displacement.

The accelerometer 122 can operate singly, as an integrated unit with theload sensing platform 121, and/or as an integrated unit with the sensingassemblies 123. Integrating one or more accelerometers 122 within thesensing assemblages 123 to determine position, attitude, movement, oracceleration of sensing assemblages 123 enables augmentation ofpresentation of data to accurately identify, but not limited to,orientation or spatial distribution of load, force, pressure,displacement, density, or viscosity, or localized temperature bycontrolling the load and position sensing assemblages to measure theparameter or parameters of interest relative to specific orientation,alignment, direction, or position as well as movement, rotation, oracceleration along any axis or combination of axes. Measurement of theparameter or parameters of interest may also be made relative to theearth's surface and thus enable computation and presentation of spatialdistributions of the measured parameter or parameters relative to thisframe of reference.

In one embodiment, the accelerometer 122 includes direct current (DC)sensitivity to measure static gravitational pull with load and positionsensing assemblages to enable capture of, but not limited to,distributions of load, force, pressure, displacement, movement,rotation, or acceleration by controlling the sensing assemblages tomeasure the parameter or parameters of interest relative to orientationswith respect to the earths surface or center and thus enable computationand presentation of spatial distributions of the measured parameter orparameters relative to this frame of reference.

Embodiments of device 100 are broadly directed to measurement ofphysical parameters, and more particularly, to evaluating changes in thetransit time of a pulsed energy wave propagating through a medium.In-situ measurements during orthopedic joint implant surgery would be ofsubstantial benefit to verify an implant is in balance and underappropriate loading or tension. In one embodiment, the instrument issimilar to and operates familiarly with other instruments currently usedby surgeons. This will increase acceptance and reduce the adoption cyclefor a new technology. The measurements will allow the surgeon to ensurethat the implanted components are installed within predetermined rangesthat maximize the working life of the joint prosthesis and reduce costlyrevisions. Providing quantitative measurement and assessment of theprocedure using real-time data will produce results that are moreconsistent. A further issue is that there is little or no implant datagenerated from the implant surgery, post-operatively, and long term.Device 100 can provide implant status data to the orthopedicmanufacturers and surgeons. Moreover, data generated by directmeasurement of the implanted joint itself would greatly improve theknowledge of implanted joint operation and joint wear thereby leading toimproved design and materials.

In at least one exemplary embodiment, an energy pulse is directed withinone or more waveguides in device 100 by way of pulse mode operations andpulse shaping. The waveguide is a conduit that directs the energy pulsein a predetermined direction. The energy pulse is typically confinedwithin the waveguide. In one embodiment, the waveguide comprises apolymer material. For example, urethane or polyethylene are polymerssuitable for forming a waveguide. The polymer waveguide can becompressed and has little or no hysteresis in the system. In oneembodiment, the waveguide is less than 10 millimeters in height. Theform factor allows integration into artificial implantable components,tools, and equipment. Conversely, the muscular-skeletal system itselfcan be the conduit for energy waves and more specifically measuredenergy wave propagation. In one embodiment, the energy pulse is directedthrough bone of the muscular-skeletal system to measure bone density. Atransit time of an energy pulse is related to the material properties ofa medium through which it traverses. This relationship is used togenerate accurate measurements of parameters such as distance, weight,strain, pressure, wear, vibration, viscosity, and density to name but afew.

A surgeon can affix a femoral prosthetic component 104 to the femur 102and a tibial prosthetic component 106 to the patient's tibia 108. Thetibial prosthetic component 106 can be a tray or plate affixed to aplanarized proximal end of the tibia 108. The load sensing insert device100 is fitted between the plate of the tibial prosthetic component 106and the femoral prosthetic component 104. These three prostheticcomponents (104, 100 and 106) enable the prostheses to emulate thefunctioning of a natural knee joint. It can measure loads at variouspoints (or locations) on the femoral prosthetic component 104 in view ofthe position and acceleration data and transmit the measured data to areceiving station 110. The receiving station 110 can include dataprocessing, storage, or display, or combination thereof and provide realtime graphical representation of the level and distribution of the loadwhen the load sensing device 100 is stationary and in motion.

A proximal end of tibia 108 is prepared to receive tibial prostheticcomponent 106. Tibial prosthetic component 106 is a support structurethat is fastened to the proximal end of the tibia and is usually made ofa metal or metal alloy. The tibial prosthetic component 106 also retainsthe insert in a fixed position with respect to tibia 108. The insert isfitted between femoral prosthetic component 104 and tibial prostheticcomponent 106. The insert has at least one bearing surface that is incontact with at least condyle surface of femoral prosthetic component104. The condyle surface can move in relation to the bearing surface ofthe insert such that the lower leg can rotate under load. The insert istypically made of a high wear plastic material that minimizes friction.

The condyle surface of femoral component 104 contacts a major surface ofdevice 100. The major surface of device 100 approximates a surface ofthe insert. Tibial prosthetic component 106 can include a cavity or trayon the major surface that receives and retains an insert dock 202 and asensing module 200 during a measurement process. Tibial prostheticcomponent 106 and device 100 have a combined thickness that represents acombined thickness of tibial prosthetic component 106 and a final (orchronic) insert of the knee joint.

In one embodiment, two devices 100 are fitted into two separatecavities, the cavities are within a trial insert (that may also bereferred to as the tibial insert, rather than the tibial componentitself) that is held in position by tibial component 106. One or twodevices 100 may be inserted between femoral prosthetic component 104 andtibial prosthetic component 106. Each sensor is independent and eachmeasures a respective condyle of femur 102. Separate sensors alsoaccommodate a situation where a single condyle is repaired and only asingle sensor is used. Alternatively, the electronics can be sharedbetween two sensors to lower cost and complexity of the system. Theshared electronics can multiplex between each sensor module to takemeasurements when appropriate. Measurements taken by device 100 aid thesurgeon in modifying the absolute loading on each condyle and thebalance between condyles. Although shown for a knee implant, device 100can be used to measure other orthopedic joints such as the spine, hip,shoulder, elbow, ankle, wrist, interphalangeal joint,metatarsophalangeal joint, metacarpophalangeal joints, and others.Alternatively, device 100 can also be adapted to orthopedic tools toprovide measurements.

The prosthesis incorporating device 100 emulates the function of anatural knee joint. Device 100 can measure loads or other parameters atvarious points throughout the range of motion. Data from device 100 istransmitted to a receiving station 110 via wired or wirelesscommunications. In a first embodiment, device 100 is a disposablesystem. Device 100 can be disposed of after using the load sensinginsert device 100 to optimally fit the joint implant. Device 100 is alow cost disposable system that reduces capital costs, operating costs,facilitates rapid adoption of quantitative measurement, and initiatesevidentiary based orthopedic medicine. In a second embodiment, amethodology can be put in place to clean and sterilize device 100 forreuse. In a third embodiment, device 100 can be incorporated in a toolinstead of being a component of the replacement joint. The tool can bedisposable or be cleaned and sterilized for reuse. In a fourthembodiment, device 100 can be a permanent component of the replacementjoint. Device 100 can be used to provide both short term and long termpost-operative data on the implanted joint. In a fifth embodiment,device 100 can be coupled to the muscular-skeletal system. In all of theembodiments, receiving station 110 can include data processing, storage,or display, or combination thereof and provide real time graphicalrepresentation of the level and distribution of the load. Receivingstation 110 can record and provide accounting information of device 100to an appropriate authority.

In an intra-operative example, device 100 can measure forces (Fx, Fy,and Fz) with corresponding locations and torques (e.g. Tx, Ty, and Tz)on the femoral prosthetic component 104 and the tibial prostheticcomponent 106. The measured force and torque data is transmitted toreceiving station 110 to provide real-time visualization for assistingthe surgeon in identifying any adjustments needed to achieve optimaljoint pressure and balancing. The data has substantial value indetermining ranges of load and alignment tolerances required to minimizerework and maximize patient function and longevity of the joint.

As mentioned previously, device 100 can be used for other jointsurgeries; it is not limited to knee replacement implant or implants.Moreover, device 100 is not limited to trial measurements. Device 100can be incorporated into the final joint system to provide datapost-operatively to determine if the implanted joint is functioningcorrectly. Early determination of a problem using device 100 can reducecatastrophic failure of the joint by bringing awareness to a problemthat the patient cannot detect. The problem can often be rectified witha minimal invasive procedure at lower cost and stress to the patient.Similarly, longer term monitoring of the joint can determine wear ormisalignment that if detected early can be adjusted for optimal life orreplacement of a wear surface with minimal surgery thereby extending thelife of the implant. In general, device 100 can be shaped such that itcan be placed or engaged or affixed to or within load bearing surfacesused in many orthopedic applications (or used in any orthopedicapplication) related to the musculoskeletal system, joints, and toolsassociated therewith. Device 100 can provide information on acombination of one or more performance parameters of interest such aswear, stress, kinematics, kinetics, fixation strength, ligament balance,anatomical fit and balance.

FIG. 9 is a perspective view of the medical device in accordance withone embodiment. As illustrated, the load sensing insert device 100 caninclude a sensing module 200 and an insert 202. The sensing Module 200can securely fit within the insert dock 202. The insert dock 202 cansecurely attach or slide onto the tibial prosthetic component 106 (seeFIG. 8). The prosthetic components of FIG. 9 can be manually coupledprior to surgical placement or during the surgery. The sensing module200 in other embodiments (without the insert dock 202) can affixdirectly to load bearing surfaces exposed to forces, for example, forcesapplied upon a load bearing component during flexion of the joint.Although illustrated as separate, in yet another embodiment, the sensingmodule 200 and insert dock 202 can be combined together as an integratedsensing module.

The sensing module 200 is an encapsulating enclosure with a unitary mainbody and load bearing contact surfaces that can be, but are not limitedto, dissimilar materials, combined to form a hermetic module or device.The components of the encapsulating enclosure may also consist of, butare not limited to, bio-compatible materials. For medical applications,the encapsulating enclosure may be required to be hermetic. Theencapsulating enclosure can comprise biocompatible materials, forexample, but not limited to, polycarbonate, steel, silicon, neoprene,and similar materials.

As will be discussed ahead, electronic assemblage within the sensingmodule 200 integrates a power supply, sensing elements, ultrasoundresonator or resonators or transducer or transducers and ultrasoundwaveguide waveguides, biasing spring or springs or other form of elasticmembers, an accelerometer, antennas and electronic circuitry thatprocesses measurement data as well as controls all operations ofultrasound generation, propagation, and detection and wirelesscommunications. The electronics assemblage also supports testability andcalibration features that assure the quality, accuracy, and reliabilityof the completed wireless sensing module or device. A temporarybi-directional interconnect assures a high level of electricalobservability and controllability of the electronics. The testinterconnect also provides a high level of electrical observability ofthe sensing subsystem, including the transducers, waveguides, andmechanical spring or elastic assembly. Carriers or fixtures emulate thefinal enclosure of the completed wireless sensing module or deviceduring manufacturing processing thus enabling capture of accuratecalibration data for the calibrated parameters of the finished wirelesssensing module or device. These calibration parameters are stored withinthe on-board memory integrated into the electronics assemblage.

FIG. 10 is an exemplary block diagram of the components of a sensingmodule. It should be noted that the sensing module could comprise moreor less than the number of components shown. As illustrated, the sensingmodule includes one or more sensing assemblages 303, a transceiver 320,an energy storage 330, electronic circuitry 307, one or more mechanicalsupports 315 (e.g., springs), and an accelerometer 302. In thenon-limiting example, an applied compressive force can be measured bythe sensing module.

The sensing assemblage 303 can be positioned, engaged, attached, oraffixed to the contact surfaces 306. Mechanical supports 315 serve toprovide proper balancing of contact surfaces 306. In at least oneexemplary embodiment, contact surfaces 306 are load-bearing surfaces. Ingeneral, the propagation structure 305 is subject to the parameter beingmeasured. Surfaces 306 can move and tilt with changes in applied load;actions which can be transferred to the sensing assemblages 303 andmeasured by the electronic circuitry 307. The electronic circuitry 307measures physical changes in the sensing assemblage 303 to determineparameters of interest, for example a level, distribution and directionof forces acting on the contact surfaces 306. In general, the sensingmodule is powered by the energy storage 330.

As one example, the sensing assemblage 303 can comprise an elastic orcompressible propagation structure 305 between a transducer 304 and atransducer 314. In the current example, transducer 304 can be anultrasound (or ultrasonic) resonator, and the elastic or compressiblepropagation structure 305 can be an ultrasound (or ultrasonic) waveguide(or waveguides). The electronic circuitry 307 is electrically coupled tothe sensing assemblages 303 and translates changes in the length (orcompression or extension) of the sensing assemblages 303 to parametersof interest, such as force. It measures a change in the length of thepropagation structure 305 (e.g., waveguide) responsive to an appliedforce and converts this change into electrical signals which can betransmitted via the transceiver 320 to convey a level and a direction ofthe applied force. In other arrangements herein contemplated, thesensing assemblage 303 may require only a single transducer. In yetother arrangements, the sensing assemblage 303 can includepiezoelectric, capacitive, optical or temperature sensors or transducersto measure the compression or displacement. It is not limited toultrasonic transducers and waveguides.

The accelerometer 302 can measure acceleration and static gravitationalpull. Accelerometer 302 can be single-axis and multi-axis accelerometerstructures that detect magnitude and direction of the acceleration as avector quantity. Accelerometer 302 can also be used to senseorientation, vibration, impact and shock. The electronic circuitry 307in conjunction with the accelerometer 302 and sensing assemblies 303 canmeasure parameters of interest (e.g., distributions of load, force,pressure, displacement, movement, rotation, torque and acceleration)relative to orientations of the sensing module with respect to areference point. In such an arrangement, spatial distributions of themeasured parameters relative to a chosen frame of reference can becomputed and presented for real-time display.

The transceiver 320 comprises a transmitter 309 and an antenna 310 topermit wireless operation and telemetry functions. In variousembodiments, the antenna 310 can be configured by design as anintegrated loop antenna. As will be explained ahead, the integrated loopantenna is configured at various layers and locations on the electronicsubstrate with electrical components and by way of electronic controlcircuitry to conduct efficiently at low power levels. Once initiated thetransceiver 320 can broadcast the parameters of interest in real-time.The telemetry data can be received and decoded with various receivers,or with a custom receiver. The wireless operation can eliminatedistortion of, or limitations on, measurements caused by the potentialfor physical interference by, or limitations imposed by, wiring andcables connecting the sensing module with a power source or withassociated data collection, storage, display equipment, and dataprocessing equipment.

The transceiver 320 receives power from the energy storage 330 and canoperate at low power over various radio frequencies by way of efficientpower management schemes, for example, incorporated within theelectronic circuitry 307. As one example, the transceiver 320 cantransmit data at selected frequencies in a chosen mode of emission byway of the antenna 310. The selected frequencies can include, but arenot limited to, ISM bands recognized in International TelecommunicationUnion regions 1, 2 and 3. A chosen mode of emission can be, but is notlimited to, Gaussian Frequency Shift Keying, (GFSK), Amplitude ShiftKeying (ASK), Phase Shift Keying (PSK), Minimum Shift Keying (MSK),Frequency Modulation (FM), Amplitude Modulation (AM), or other versionsof frequency or amplitude modulation (e.g., binary, coherent,quadrature, etc.).

The antenna 310 can be integrated with components of the sensing moduleto provide the radio frequency transmission. The substrate for theantenna 310 and electrical connections with the electronic circuitry 307can further include a matching network. This level of integration of theantenna and electronics enables reductions in the size and cost ofwireless equipment. Potential applications may include, but are notlimited to any type of short-range handheld, wearable, or other portablecommunication equipment where compact antennas are commonly used. Thisincludes disposable modules or devices as well as reusable modules ordevices and modules or devices for long-term use.

The energy storage 330 provides power to electronic components of thesensing module. It can be charged by wired energy transfer,short-distance wireless energy transfer or a combination thereof.External power sources can include, but are not limited to, a battery orbatteries, an alternating current power supply, a radio frequencyreceiver, an electromagnetic induction coil, a photoelectric cell orcells, a thermocouple or thermocouples, or an ultrasound transducer ortransducers. By way of the energy storage 330, the sensing module can beoperated with a single charge until the internal energy is drained. Itcan be recharged periodically to enable continuous operation. The energystorage 330 can utilize common power management technologies such asreplaceable batteries, supply regulation technologies, and chargingsystem technologies for supplying energy to the components of thesensing module to facilitate wireless applications.

The energy storage 330 minimizes additional sources of energy radiationrequired to power the sensing module during measurement operations. Inone embodiment, as illustrated, the energy storage 330 can include acapacitive energy storage device 308 and an induction coil 311. Externalsource of charging power can be coupled wirelessly to the capacitiveenergy storage device 308 through the electromagnetic induction coil orcoils 311 by way of inductive charging. The charging operation can becontrolled by power management systems designed into, or with, theelectronic circuitry 307. As one example, during operation of electroniccircuitry 307, power can be transferred from capacitive energy storagedevice 308 by way of efficient step-up and step-down voltage conversioncircuitry. This conserves operating power of circuit blocks at a minimumvoltage level to support the required level of performance.

In one configuration, the energy storage 330 can further serve tocommunicate downlink data to the transceiver 320 during a rechargingoperation. For instance, downlink control data can be modulated onto theenergy source signal and thereafter demodulated from the induction coil311 by way of electronic control circuitry 307. This can serve as a moreefficient way for receiving downlink data instead of configuring thetransceiver 320 for both uplink and downlink operation. As one example,downlink data can include updated control parameters that the sensingmodule uses when making a measurement, such as external positionalinformation, or for recalibration purposes, such as spring biasing. Itcan also be used to download a serial number or other identificationdata.

The electronic circuitry 307 manages and controls various operations ofthe components of the sensing module, such as sensing, power management,telemetry, and acceleration sensing. It can include analog circuits,digital circuits, integrated circuits, discrete components, or anycombination thereof. In one arrangement, it can be partitioned amongintegrated circuits and discrete components to minimize powerconsumption without compromising performance. Partitioning functionsbetween digital and analog circuit enhances design flexibility andfacilitates minimizing power consumption without sacrificingfunctionality or performance. Accordingly, the electronic circuitry 307can comprise one or more Application Specific Integrated Circuit (ASIC)chips, for example, specific to a core signal processing algorithm.

In another arrangement, the electronic circuitry can comprise acontroller such as a programmable processor, a Digital Signal Processor(DSP), a microcontroller, or a microprocessor, with associated storagememory and logic. The controller can utilize computing technologies withassociated storage memory such a Flash, ROM, RAM, SRAM, DRAM or otherlike technologies for controlling operations of the aforementionedcomponents of the sensing module. In one arrangement, the storage memorymay store one or more sets of instructions (e.g., software) embodyingany one or more of the methodologies or functions described herein. Theinstructions may also reside, completely or at least partially, withinother memory, and/or a processor during execution thereof by anotherprocessor or computer system.

FIG. 11 is an illustration of a plot of non-overlapping resonantfrequencies of paired transducers in accordance with an exemplaryembodiment. In a non-limiting example, the characteristics of transducerA correspond to a first transducer driven by a transducer driver circuitas disclosed herein. The first transducer emits an energy wave into amedium at a first location. The characteristics of transducer Bcorrespond to a second transducer for receiving a propagated energywave. Transducer B outputs a signal corresponding to the propagatedenergy wave. Operation too close to their resonant frequencies resultsin substantial changes in phase, but limits shifts in frequency withchanges in propagation through the waveguide or propagation medium. Oneapproach to avoiding operation where the frequency of operation of anembodiment of a propagation tuned oscillator is bound this way is toselect transducers with different resonant frequencies. The twotransducers may be selected such that their respective series andparallel resonant frequencies do not overlap. That is, that bothresonant frequencies of one transducer must be higher than eitherresonant frequency of the other transducer. This approach has thebenefit of substantial, monotonic shifts in operating frequency of thepresent embodiment of a propagation tuned oscillator with changes in thetransit time of energy or ultrasound waves within the waveguide orpropagation medium with minimal signal processing, electricalcomponents, and power consumption

Measurement of the changes in the physical length of individualultrasound waveguides may be made in several modes. Each assemblage ofone or two ultrasound resonators or transducers combined with anultrasound waveguide may be controlled to operate in six differentmodes. This includes two wave shape modes: continuous wave or pulsedwaves, and three propagation modes: reflectance, unidirectional, andbi-directional propagation of the ultrasound wave. The resolution ofthese measurements can be further enhanced by advanced processing of themeasurement data to enable optimization of the trade-offs betweenmeasurement resolution versus length of the waveguide, frequency of theultrasound waves, and the bandwidth of the sensing and data captureoperations, thus achieving an optimal operating point for a sensingmodule or device.

While the present invention has been described with reference toparticular embodiments, those skilled in the art will recognize thatmany changes may be made thereto without departing from the spirit andscope of the present invention. Each of these embodiments and obviousvariations thereof is contemplated as falling within the spirit andscope of the invention.

What is claimed is:
 1. A sensing assemblage for measuring a parameter ofthe musculoskeletal system comprising: a waveguide having a reflectivefeature at a first end wherein the waveguide comprises polyethylene orurethane; and a transducer coupled to a second end of the waveguidewherein the waveguide and the transducer are configured to measureloading applied to an insert when placed in a prosthetic knee joint,wherein the transducer is configured to emit ultrasound waves into thewaveguide and detect reflected ultrasound waves from the reflectivefeature, wherein the transducer is configured to output a signal upondetecting reflected energy waves that relates to a load magnitudeapplied to the insert and corresponds to a dimension of the waveguideunder load.
 2. The sensing assemblage of claim 1 wherein the waveguideis elastically compressible.
 3. The sensing assemblage of claim 1further including a controller coupled to the transducer wherein thecontroller controls the transducer to emit the ultrasound waves and thecontroller controls the transducer to detect the echo of reflectedultrasound waves.
 4. The sensing assemblage of claim 3 wherein thecontroller is configured to measure a propagation time corresponding tothe emitted ultrasound waves and the propagation time to receive thereflected ultrasound waves.
 5. The sensing assemblage of claim 4 whereinthe controller is configured to transmit measurement data to a computer.6. The sensing assemblage of claim 1 where a length of the waveguide isless than 10 millimeters.
 7. The sensing assemblage of claim 1 furtherincluding a second reflective, wherein the second reflective feature isplaced within the waveguide between the first end and the second end ofthe waveguide.
 8. The sensing assemblage of claim 1 wherein thetransducer comprises a piezoelectric element.
 9. The sensing assemblageof claim 1 wherein the ultrasound waves comprise ultrasound pulses. 10.The sensing assemblage of claim 1 wherein a length of the waveguide is 1millimeter or less.
 11. The sensing assemblage of claim 1 where thewaveguide is configured in two or more axes.
 12. The sensing assemblageof claim 3 wherein the controller is configured to couple to anaccelerometer.
 13. The sensing assemblage of claim 12 wherein theaccelerometer couples to the insert and wherein the accelerometer isconfigured to measure motion or position of the knee joint.
 14. Thesensing assemblage of claim 1 wherein the ultrasound waves comprisecontinuous waves.